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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACQUIRE PULMONARY; BRONCHOSCOPE (FLEXIBLE OR RIGID)
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BOSTON SCIENTIFIC CORPORATION ACQUIRE PULMONARY; BRONCHOSCOPE (FLEXIBLE OR RIGID) Back to Search Results
Model Number M00552400
Medical Device Problem Codes Material Deformation (2976); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/09/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Premarket/510(k) #: k163248 & k151895.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
 
Event or Problem Description
It was reported to boston scientific corporation that an acquire pulmonary needle was used in the lungs during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, stylet kinked inside the needle.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.
 
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Brand Name
ACQUIRE PULMONARY
Common Device Name
BRONCHOSCOPE (FLEXIBLE OR RIGID)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10951471
Report Number3005099803-2020-05752
Device Sequence Number6233342
Product Code EOQ
UDI-Device Identifier08714729986249
UDI-Public08714729986249
Combination Product (Y/N)N
Initial Reporter CountryAS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 12/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date03/24/2022
Device Model NumberM00552400
Device Catalogue Number5240
Device Lot Number0023538423
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/09/2020
Initial Report FDA Received Date12/05/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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